Engineering Psychedelics: $22M Pool For Clinical Trials Of Compounds Targeting CNS Disorders

NYC and Cambridge-based Empyrean Neuroscience Inc. is a new genetic engineering company developing neuroactive compounds for neuropsychiatric and neurological disorders launching with a $22 million Series A financing.

The company’s CEO is long-time biotech executive Dr. Usman “Oz” Azam, joined by Dr. Fred Grossman as chief medical officer. Azam has previously worked on genetic engineering with Dr. Carl June of the University of Pennsylvania, while Grossman is a psychiatrist that holds expertise in CNS-targeted small molecules development.

Both leadmen say the goal is to target the demand gap within the mental health disorders scenario. “The best treatment available in psychiatry over the past 50 years is less than 50% effective,” stated Dr. Grossman.

Dr. Azam echoed the comment: “There is an enormous medical need for safe and effective therapeutics that treat neuropsychiatric and neurologic disorders and we believe genetic engineering provides the answer.

“By applying our genetic engineering platform to make precise modifications to the genomes of fungi and plants, we can change the amount and kind of neuroactive small molecules they produce, with the goal of developing safe and effective treatments for difficult-to-treat diseases of the CNS.” 

The initial funding will be used to create small molecule therapeutics through precision genetic modification, transformation and regeneration of fungi and plants with potential therapeutic properties for CNS disorders, with initial focus set on Major Depressive Disorder (MDD) and then moving on to PTSD, substance abuse and dependence, chronic pain and neurological disorders as a whole.

Reuniting the work of plant biologists and genetic engineers, Empyrean is setting out a homegrown technology without licensing out academic IP for plants and fungi, a new class of therapeutics they named “mycogenomic” and “phytogenomic” molecules. Its developmental pipeline includes fungal alkaloids, cannabinoids and other neuroactive compounds such as DMT. 

Dr. Grossman further explained the company’s standpoint: “Fungal alkaloids and cannabinoids have shown promise in treating depression, PTSD, anxiety, and other neuropsychiatric and neurologic disorders. We believe our approach of genetically engineering fungi and plants can improve their safety and efficacy and will ultimately help to address the substantial unmet medical need in patients who suffer from these diseases.”

IND-enabling studies of Empyrean’s first genetically-engineered encapsulated mushroom drug product are currently underway, and the company expects to enter clinical trials for MDD in 2023. Moreover, it has licensed CRISPR/Cas9 technology from ERS Genomics for genetic engineering applications related to its therapeutic pipeline. 

Details On The Novel Gene Technology Application

In a recent interview, Azam explained: “The whole premise is applying genetic engineering technology that we use in oncology and T-cell engineering to species of fungi and plants for creating a whole new class of therapies. We don’t know anybody else doing this with the focus on neuropsychiatry and neurology.”

What makes Empyrean’s approach different from other companies extracting neuroactive compounds is that the company is set to take advantage of other natural compounds present in fungi and plants. For instance mushrooms, besides psilocybin, have alkaloids compounds present in them, which hold an “entourage effect” that “may allow for these alkaloids to enhance the clinical effect that we would expect from psilocybin,” Dr. Grossman explained.

“This platform is so exciting because you can apply genetic engineering and create concentrations of effective neuroactive molecules in plants and fungi that have never been seen before. We’ve never seen this in psychiatry, and that’s why everyone is leaning in,” he said. 

Photo by Thomas Verbruggen on Unsplash